Kornimate/medical-research-clean huggingface dataset:
study of milnacipran in patients with inadequate response to duloxetine for the treatment of fibromyalgia

Conditions: Fibromyalgia

Summary: the objective of this study is to evaluate the safety, tolerability and efficacy of milnacipran in patients with an inadequate response to duloxetine for the treatment of fibromyalgia.

* two weeks duloxetine 60 mg open-label period * randomization to double-blind treatment period: 10 weeks milnacipran (direct switch) or 10 weeks placebo (one week blinded 30 mg duloxetine) * one week double-blind down-taper period

Eligibility criteria:
inclusion criteria: * diagnosis of fibromyalgia * have been treated with a stable dosage of duloxetine (60 mg/day) for ≥ 4 weeks immediately before screening (visit 1) * duloxetine must have been prescribed for the treatment of fibromyalgia * have a vas 1-week pain recall score ≥ 40 mm and ≤ 90 mm * at visit 2, to be eligible to enter the randomized treatment period, must continue to have a vas 1-week pain recall score ≥ 40 mm and be dissatisfied with current duloxetine treatment. exclusion criteria: * suicidal risk * history of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder * myocardial infarction and/or stroke within the prior 6 months * systolic blood pressure \> 160 mm hg or mean diastolic blood pressure \> 100 mm hg at screening (visit 1) * substance abuse * pulmonary dysfunction * severe renal impairment * active cardiac disease * liver disease * uncontrolled narrow-angle glaucoma * autoimmune disease * cancer * inflammatory bowel disease * unstable endocrine disease * prostatic enlargement * female patients who are pregnant or breastfeeding

Keywords: milnacipran duloxetine switch forest research institute
special drug use investigation for clavamox® (amoxicillin/clavulanate) pediatrics dry syrup (every indication excluded otitis media)

Conditions: Otitis Maedia

Summary: this post-marketing surveillance study of clavamox® was designed to collect and assess the information on proper use, such as safety and efficacy, under actual use conditions, targeting pediatric japanese patients with diseases (superficial skin infection, deep skin infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis, tonsillitis, acute bronchitis, cystitis, pyelonephritis) other than otitis media. ("clavamox" is a trademark of the glaxosmithkline group of companies.)


Eligibility criteria:
inclusion criteria: * pediatric subjects with diseases of superficial skin infection, deep skin infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis, tonsillitis, acute bronchitis, cystitis and pyelonephritis exclusion criteria: * not applicable
data collection registry of the hero graft for end stage renal disease patients receiving hemodialysis

Conditions: End Stage Renal Failure on Dialysis

Summary: data collection registry of the hero graft for end stage renal disease patients receiving hemodialysis

data collection including medical history, operative procedure data, and follow-up data every six months while using the hero graft for dialysis, including: * post-operative complications for hero graft implantation * length of time between insertion and use of hero graft * incidence of thrombosis * hospitalizations * incidence of infections and other adverse event occurrence * mortality * hemoglobin * kt/v * pre-dialysis blood pressure * post-dialysis blood pressure * blood flow rate and * dialysis flow rate

Eligibility criteria:
inclusion criteria: * all patients eligible for hero graft for dialysis access * age greater than 18 years old * able to give informed consent exclusion criteria: * subjects with any kind of disorder that compromises the ability of the subject to give informed consent and/or to comply with the study procedures; * any medical condition that in the opinion of the investigator may pose a safety risk to a subject in the study or which may interfere with study participation.

Keywords: hero graft
cook iliac branch graft post-market registry

Conditions: Iliac Aneurysm; Aortic Aneurysm

Summary: the cook iliac branch graft post-market registry will obtain case reports of physician experience with a ce-marked cook iliac branch graft to further confirm device safety and performance.


Eligibility criteria:
inclusion criteria: * ce-marked cook iliac branch graft (e.g., zenith® branch endovascular graft-iliac bifurcation, zenith® helical branch endovascular graft) * registry data are de-identified with respect to patient. exclusion criteria: * patient for whom this device would not normally be considered standard of care.

Keywords: iliac aneurysm aortic aneurysm endovascular grafts
urinalysis results in healthy individuals

Conditions: Asymptomatic Bacteriuria; Asymptomatic Pyuria

Summary: this is a prospective, observational study assessing the results of urine dipsticks on adult volunteers with no acute symptoms. we seek to determine the frequency of leukocytes or nitrites in this group of individuals.

the urinalysis (ua) is one of the most commonly utilized tests in the emergency department (ed). in some busy eds, a ua is routinely ordered by protocol on patients with abdominal pain, and in elderly patients, a ua is often ordered for a variety of chief complaints including dizziness and altered mental status. when these patients, who often do not specifically have symptoms of a urinary tract infection, have a urinalysis demonstrating pyuria or bacteria, it may be interpreted as an atypical presentation of a uti. however, it is possible that these patients do not have urinary tract infections, but have baseline pyuria or bacteriuria. one prior study found that 5% of sexually active healthy women 18-40 have asymptomatic bacteriuria \[1\], and the rate of asymptomatic bacteriuria increases with age, such that it is present in 8-10% of women from 70-80 years of age \[2\]. moreover, one prior article stated that 30-50% of residents of long term nursing facilities have positive urine cultures at any given time \[3\]. the above statistics come from the results of urine cultures. in the ed, the decision to treat or not treat a patient for a uti is not made based upon culture results, but upon a urinalysis (microscopic or dipstick). only one prior study has looked at the frequency of abnormal urinalyses in healthy individuals, and it found that over a third of asymptomatic women had at least 1+ leukocytes in their urine \[4\]. this is evidence that a substantial number of people who do not have symptomatic utis have uas that could be interpreted as utis. if these results could be replicated and expanded to include a wider group of individuals (males, elderly patients, various races, etc.), it would provide valuable information about how we can better interpret and utilize the results of a ua. thus, the investigators propose a prospective study to assess the frequency of abnormal uas in a wide variety of individuals without acute symptoms. urine samples will be obtained from adults with no acute symptoms, and performed urine dipsticks to assess the frequency of leukocytes or nitrites in the urine. patients will be divided into groups to determine if there are certain factors (gender, age, or medical history) that increase the chance of having leukocytes or nitrites in the urine.

Eligibility criteria:
inclusion criteria: * age \> 18 years * able to spontaneously provide a urine sample exclusion criteria: * any acute symptoms (including but not limited to vaginal bleeding, vaginal discharge, abdominal pain, back pain, dysuria, hematuria, and fever) * pregnancy * prisoner status * antibiotics within 72 hours * urologic procedure within a week
induced pluripotent stem cells for the development of novel drug therapies for inborn errors of metabolism (ipsc-iem)

Conditions: Inborn Errors of Metabolism

Summary: human induced pluripotent stem cells (ipscs), are reprogrammed from somatic cells that can self-renew indefinitely and produce different types of cells. they provide human model cell lines for orphan drug development. it is the goal of this study to define new cellular disease models for inborn erors of metabolism, as enabling tools for both drug discovery and development.


Eligibility criteria:
inclusion criteria: * informed consent is obtained from the participant or from the parent/ legal guardian * the participant is aged between 2 months and 50 years * the diagnosis of an inborn error of metabolism (iem) is genetically confirmed by centogene * the participant is a first-degree or a second-degree relative of an individual with inborn error of metabolism (iem) genetically confirmed by centogene exclusion criteria: * inability to provide informed consent * the participant is younger than 2 months or older than 50 years * the diagnosis of an inborn error of metabolism (iem) is not genetically confirmed by centogene and * the participant is not a first-degree or a seconddegree relative of an individual with inborn error of metabolism (iem) genetically confirmed by centogene * previously enrolled in the study
family research study: metabolism of fats and proteins in specific ethnic groups

Conditions: Healthy; Heart Disease

Summary: the purpose of this study is to determine whether lipoprotein(a), also called lp(a), is a risk factor for cardiovascular (heart) disease. lipoproteins are tiny particles that circulate in the blood. they contain cholesterol, fat, and protein in varying amounts depending on the body's need. higher levels of lipoproteins in the blood can cause an increased risk of heart disease. the investigators believe that by studying the lp(a) lipoprotein in caucasians and african americans, the investigators can assess for genetic variation factors related to cardiovascular (heart) disease. the investigators will be looking at 100 african-american families and 100 caucasian families to confirm whether a higher lp(a) level is an indicator of a higher risk for heart disease.

during the study visit the research staff will ask about the medical history, perform a brief physical exam, and draw approximately 4 teaspoons of blood of each family member.

Eligibility criteria:
inclusion criteria: * of caucasian or african descent * families must have 2 natural/biological parents and 2 natural/biological offspring * 6 years old or older exclusion criteria: * races other than african american or caucasian * families without 2 natural/biological parents and 2 natural/biological offspring * younger that 6 years old

Keywords: heart disease cardiovascular disease lipoproteins lipoprotein(a) lp(a) apolipoprotein(a) apo(a) fats proteins metabolism
quality of life impact of chronic rhinitis treatment with aerin medical device

Conditions: Chronic Rhinitis

Summary: evaluation of long-term (2-year) quality of life and symptoms after chronic rhinitis treatment with the aerin inseca/rhinaer stylus

this is a prospective, non-randomized, multicenter follow-up study to collect long-term data on a cohort of patients who participated in the aerin medical tp668 study, "clinical evaluation of low power radiofrequency energy applied to the posterior nasal nerve area for symptomatic relief of chronic rhinitis". the study will be conducted in a maximum of 5 centers that participated and enrolled patients in the tp668 study.

Eligibility criteria:
inclusion criteria: * received treatment for chronic rhinitis in aerin study tp668 exclusion criteria: * unwilling to participate in this long-term study

Keywords: chronic rhinitis posterior nasal nerve quality of life
genetic linkage study for hereditary pancreatitis

Conditions: Pancreatitis

Summary: the purpose of this study is to establish linkage in families with hereditary pancreatitis (hp) to the cationic trypsinogen gene or other, as yet unknown, hp gene(s).

hereditary pancreatitis (hp) is an inflammatory condition of the pancreas which is usually recurrent in nature and occurs in blood-related persons over two or more generations. it is an autosomal dominant trait with complete penetrance by variable expression. symptoms are usually present during childhood and it is the second most common cause of chronic or recurrent pancreatitis in children. hp is a primary disorder and can therefore be differentiated from other inherited disorders that cause secondary pancreatitis. the purpose of this study is to establish linkage in families with hp between the phenotype and a chromosomal locus (loci) which contains the responsible gene. affected families are recruited to donate a blood sample through referral from their primary physician or self-referral. the potential significance lies in the identification of the genetic defect causing hp and understanding the pathophysiologic mechanism of the disease. typically families with hp have a high incidence of adenocarcinoma of the pancreas and identification of the cause of this disease may provide critical insights into the cause of pancreatic cancer. blood samples are collected from patients and family members. dna is extracted from the blood and used for genotypic analysis and linkage analysis. patients do not necessarily receive the results of the genetic testing and the results do not influence the type or duration of treatment.

Eligibility criteria:
inclusion criteria: 1. diagnosis of pancreatitis at age \< 60 or 2. diagnosis of pancreatitis at any age and at least one other 1st or 2nd degree relative with a diagnosis of pancreatitis or pancreatic cancer or 3. diagnosis of pancreatic cancer and a 1st or 2nd degree relative with pancreatic cancer or pancreatitis or 4. diagnosis of pancreatic insufficiency or maldigestion that improves with pancreatic enzyme replacement or 5. close family members (parents, grandparents, siblings cousins - anyone related by blood) of subjects who meet criteria 1, 2, or 3 and 6. age 3 months up to 100 years exclusion criteria: there are no general exclusions.
promoting successful weight loss in primary care in louisiana using information technology

Conditions: Obesity; Diabetes Mellitus, Type 2; PreDiabetes

Summary: the primary aim is to test the effectiveness of an innovative 24-month pragmatic and scalable weight-loss centric approach using a collaborative care model that connects patients with a non-primary care practitioner (pcp) health coach who delivers care remotely to patients through the patient portal of an electronic medical record (emr).

this study is a 24-month, two-arm, parallel controlled trial in a primary care setting. a total of 352 black adults with obesity and type 2 diabetes or prediabetes will be randomized to either 1) intervention or 2) usual care. the intervention arm will receive a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 american heart association/american college of cardiology/the obesity society obesity guidelines, delivered remotely using ehealth technology, by trained health coaches embedded in the digital medicine group in the ochsner health system. the intervention will include remote sessions with the health coach using evidence-based components such as the use of portion control and various behavioral strategies. patients in the usual care arm will receive their normal, usual care from their primary care team. all patients will participate in the collection of patient-reported outcomes at baseline and approximately 6, 12, and 24 months.

Eligibility criteria:
inclusion criteria: * 40-70 years of age * self-identify as black/african american * obesity (bmi 30.0-50.0 kg/m2) * type ii diabetes (based on icd-10 codes, fasting plasma glucose ≥126 mg/dl, hba1c ≥6.5%, 2-h plasma glucose during 75-g oral glucose tolerance test (ogtt) ≥200 mg/dl, or a random plasma glucose ≥200 mg/dl in a patient with classic symptoms of hyperglycemia or hyperglycemic crisis) or pre-diabetes (based on icd-10 codes, fasting glucose 100-125 mg/dl or hba1c 5.7-6.4% or 2-h glucose during 75-g ogtt 140-199 mg/dl) * has an internet-connected device and is willing to use it for intervention delivery * patient in the ochsner health system with an active myochsner portal account, or willing to create one * acknowledgement from their ochsner primary care practitioner that there are no known contraindications to the patient's participation * have weight measured at an ochsner clinic within 4 weeks of screening * resident of louisiana * be able to provide informed consent * willing to change diet and/or physical activity exclusion criteria: * body weight ≥ 400 lbs. * current use of weight loss medication or recent weight loss (net loss \>10 lbs in the last six months) * currently participating in a structured weight loss program * plans to move from the area within 2 years * given birth within the past year, is currently pregnant or breastfeeding or plans to become pregnant within 2 years * past bariatric surgery or plans for bariatric surgery within 2 years * disease/condition that is life threatening or can interfere with or be aggravated by exercise or weight loss
fezolinetant for treating hot flashes in men with prostate cancer

Conditions: Prostate CA; Androgen Deprivation Therapy

Summary: this study is for men with prostate cancer who are experiencing hot flashes due to treatments that lower testosterone. hot flashes can affect your quality of life and make it harder for patients to continue their treatment, so researchers want to find a better way to manage them. the study is testing a drug called fezolinetant, which might help reduce hot flashes without using hormones. fezolinetant is a drug that is currently approved for the treatment of hot flashes in menopausal women.


Eligibility criteria:
inclusion criteria: age ≥ 18 years men who are currently receiving androgen deprivation therapy (adt) for the treatment of prostate cancer. adt is defined by a history of orchiectomy, or ongoing usage of gonadotropin-releasing hormone agonists or antagonists (e.g. leuprolide, degarelix, relugolix). men receiving androgen receptor pathway inhibitors (arpi) such as abiraterone, enzalutamide, apalutamide, and darolutamide are eligible. patients must be on a stable dose of all hormonal therapies for at least 28 days prior to registration and must not be planning to discontinue this therapy for at least 42 days following registration. additional arpi agents (e.g. abiraterone or enzalutamide) are allowed to be added during the extension phase of the trial, but not during the treatment phase. patients receiving radiation therapy during the study period are eligible. an eligible patient must have bothersome hot flashes for ≥ 7 days prior to consent, resulting in an average of four or more hot flashes per day of sufficient severity to cause the patient to seek therapeutic intervention. life expectancy of 6 months or greater. language: in order to complete the mandatory participant-completed measures, participants must be able to speak and read english. exclusion criteria: current or future planned use of any of the following agents during the study period: drugs that are not fda approved for use in humans, any drug with category x interactions with fezolinetant; androgens, estrogens, progesterone analogs, or complementary/alternative medicine taken for the purpose of managing hot flashes. prior use of these agents is permitted as long as they are discontinued before registration. stable dosing (≥ 1 month) of gabapentin, cholinergic agonists, cholinesterase inhibitors for other indications is permitted. history of cirrhosis elevated alanine aminotransferase (alt) or aspartate aminotransferase (ast) ≥ 2 x uln or total bilirubin \> uln egfr \<30 ml/min/1.73 m2 based on reported mdrd estimate. current use of cyp1a2 inhibitors (fezolinetant is a substrate of cyp1a2).

Keywords: prostate cancer androgen deprivation therapy hot flash fezolinetant
a global assessment of medical, emotional and reproductive concerns in gestational trophoblastic disease survivors

Conditions: Uterine Cancer; Cervix Uteri Nos; Gestational Trophoblastic Disease

Summary: the purpose of this study is to collect information on the effects of treatment for gestational trophoblastic disease (gtd). we plan to use the findings from this study to better understand gtd survivors' health and quality of life. we would like to know more about the health, quality of life and pregnancies of women treated for gtd. this information will be used to try and improve the treatments for women who have this disease.


Eligibility criteria:
inclusion criteria: * pathology confirmed gtd by mskcc * sufficient proficiency in the english language to respond to quality of life surveys * age ≥ 18 years * benign or malignant disease * treated with surgery and/or chemotherapy or observation exclusion criteria: * none

Keywords: gtd survivors questionnaires gtd
breathing-swallowing interaction in chronic obstructive pulmonary disease patients - impact of non invasive ventilation

Conditions: Chronic Obstructive Pulmonary Disease (COPD); Decompensated COPD With (Acute) Exacerbation

Summary: in the investigators' knowledge there are no data about the impact of non invasive mechanical ventilation on the breathing-swallowing interaction. our main objective is to evaluate breathing-swallowing interaction in chronic obstructive pulmonary disease (copd) patients hospitalized in intensive care unit for an acute exacerbation, and evaluate the impact of using non invasive mechanical ventilation (niv)

in healthy subjects previous studies showed that most swallows started during expiration and were followed by expiration, a pattern believed to contribute to airway protection during swallowing. however in healthy individuals, the occurrence of inspiration after swallows was increased by hypercapnia or application of an inspiratory elastic load. in a previous study the investigators have demonstrated that patients with neuromuscular disorders exhibited piecemeal deglutition leading to an increase in the time needed to swallow a water bolus, as well as occurrence of inspiration after nearly half the swallows. these abnormalities which increased with the decreasing of respiratory muscle performances may explain feeding difficulties. however in tracheostomized patients who could breathe spontaneously, piecemeal deglutition and swallowing time per bolus were diminished by the use of mechanical ventilation. in the investigators' knowledge there are no data about the impact of non invasive mechanical ventilation on the breathing-swallowing interaction. the investigators' main objective is to evaluate breathing-swallowing interaction in chronic obstructive pulmonary disease (copd) patients hospitalized in intensive care unit for an acute exacerbation, and evaluate the impact of using non invasive mechanical ventilation (niv)

Eligibility criteria:
inclusion criteria: * patients with chronic obstructive pulmonary disease * age \> 18 years * hospitalized in intensive care for an acute exacerbation * requiring non invasive mechanical ventilation * able to breath spontaneously without non invasive ventilation more than 4h/day * without bulbar dysfunction exclusion criteria: * hemodynamic instability * absence of consent * severe hypoxemia * ph \< 7,30 * no cooperation of the patient

Keywords: chronic obstructive pulmonary disease non invasive mechanical ventilation breathing-swallowing interaction intensive care unit